Endo-Ice-Pulp Tester-Thermal
FDA 510(k) K930764 · The Hygenic Corp.
510(k) numberK930764
Submission
- Device name
- Endo-Ice-Pulp Tester-Thermal
- Applicant
- The Hygenic Corp.
Akron, OH, US - Received
- February 12, 1993
- Decision date
- May 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K011666 | ChillitEAT · Traditional | Heatshield, Inc. | 08/06/2001SE |
| K990225 | Endo Analyzer, Model 8005, ModifiedEAT · Traditional | Sybron Dental Specialties, Inc. | 02/25/1999SE |
| K973439 | Endo Analyzer, Model 8005EAT · Traditional | Sybron Dental Specialties, Inc. | 12/08/1997SE |
| K970715 | System B Heat SourceEAT · Traditional | Sybron Dental Specialties, Inc. | 04/07/1997SE |
| K963862 | Touch N' HeatEAT · Traditional | Sybron Dental Specialties, Inc. | 12/02/1996SE |
| K960799 | Ortho-IceEAT · Traditional | Ultimate Wireforms, Inc. | 05/09/1996SE |
| K950237 | DigitestEAT · Traditional | Parkell, Inc. | 06/09/1995SE |
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| K905640 | Solid Core Gutta Percha CarrierEKS · Traditional | 03/05/1991SE |
| K900301 | Novus Bonding AgentEBI · Traditional | 05/15/1990SE |
| K900844 | WedjetsEIE · Traditional | 04/16/1990SE |
| K894092 | Dental Endodontic Cement (Modification)KIF · Traditional | 01/10/1990SE |
| K881826 | Endo-IceEAT · Traditional | 08/23/1988SN |
| K873644 | Pulp PenEAT · Traditional | 10/27/1987SE |
| K863393 | EndocaterLQY · Traditional | 06/11/1987SE |
Questions and answers
When was Endo-Ice-Pulp Tester-Thermal cleared by the FDA?
Endo-Ice-Pulp Tester-Thermal (K930764) received a 510(k) decision of Substantially Equivalent on May 27, 1993, 104 days after the submission was received.
What is the product code of K930764?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.